Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-29 @ 4:10 PM
Study NCT ID:
NCT05552495
Status:
COMPLETED
Last Update Posted:
2023-01-12
First Post:
2022-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-386 in Healthy Volunteers Under Fasting Conditions
Sponsor:
Chong Kun Dang Pharmaceutical
Organization:
Study Overview
Official Title:
A Phase I Clinical Trial to Evaluate the Tolerability and the Pharmacokinetics of CKD-386 With Co-administration of D013, D326, and D337 in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-386 in healthy volunteers under fasting conditions.
Detailed Description:
To 30 healthy subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 14 days Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: